Menthol Report Pulled Off Dais for FDA

Appointment of tobacco panel members ruled "arbitrary and capricious”

July 22, 2014

WASHINGTON -- The Food and Drug Administration can't use an advisory panel's 2011 report on menthol cigarettes because its members had conflicts of interest, a federal judge ruled Monday, according to an Associated Press report.

While the agency has since conducted an independent review on the public-health impact of menthol cigarettes, the ruling could hinder the FDA's ability to defend any future regulation of the minty smokes, the report concludes.

U.S. District Court Judge Richard Leon in Washington ordered the FDA on Monday to reconstitute the tobacco panel and barred the agency from using its older report on menthol cigarettes.

Cigarette makers Lorillard Inc. and Reynolds American Inc. sued the agency in 2011, alleging conflicts of interest and bias by several members of the panel tasked with advising the FDA on tobacco-related issues.

They argued that the panel failed to meet the federal requirements that committee members should be fairly balanced and not inappropriately influenced by any special interest. The lawsuit specifically alleged that some committee members had conflicts of interest because they were paid expert witnesses in anti-tobacco lawsuits and had financial ties to pharmaceutical companies that make smoking-cessation products.

The agency, however, argued that the panel met federal standards and that the cigarette makers' "alleged injuries are entirely speculative," according to the report.

In his order Monday, Leon said the FDA erred in determining that the members didn't have conflicts of interest and therefore, the agency's appointment of those members was "arbitrary and capricious," and tainted both the panel and its work.

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